Cancer care in the U.S. alone costs $171 billion per year. Every year, 1.4 million Americans are diagnosed with cancer, and 565,000 will die from cancer. Worldwide, 12 million individuals get cancer, with a death toll of 7 million per year, almost twice the number from malaria, AIDS, and tuberculosis combined. Current cancer patient treatment falls short because of failures at the diagnostic level. Firstly, individuals with predisposing genetic risk factors are not identified because current technology is not cost effective, and many risk factors still need to be discovered and validated. The molecular signatures of cancers are neither well understood nor rigorously profiled—because current technology is not standardized across platforms. Finally, patients who will not respond to current therapies are not identified, because current technology is not integrated with clinical trials and these profiles have not been properly identified or validated.
The present invention is directed to methods, devices, and instrumentation for nucleic acid amplification and sequencing that is designed to standardize molecular diagnosis and individualize treatment of cancer and other diseases to overcome these and other deficiencies in the art.